Kornimate/medical-research-clean huggingface dataset:
liver and biliary tumor tissue registry

Conditions: Hepatocellular Carcinoma; Cholangiocarcinoma

Summary: patients having surgery to remove a liver or biliary tissue mass or having a biopsy of a mass or lesion will have a tissue sample collected and stored for future research of liver and biliary diseases. a blood sample may also be collected at the time of enrollment.

the study establishes a tissue and blood registry at mayo clinic florida to support translational investigations into the biology, etiology and prognosis of liver and biliary masses such as through the use of patient-derived xenografts. patients having surgery to remove a liver or biliary mass or having a biopsy of a mass or lesion will be asked to donate a portion of the removed mass for research purposes. only portions of the mass not required for clinical diagnostic evaluation, or surgical waste, will be used in this research study. the tissues acquired will be stored and used for any specific, hypothesis driven protocols that are irb approved. serum and plasma samples may also be obtained at enrollment. clinical patient data from medical charts that may be correlative to outcomes will be collected and stored in a password secure data base. data will be extracted from medical records charts.

Eligibility criteria:
inclusion criteria: * scheduled to undergo surgical resection of a liver or biliary mass exclusion criteria: * under 18 years of age. prior radiation to mass.

Keywords: liver cancer biliary tract cancer cholangiocarcinoma hepatocellular carcinoma liver tumor biliary tumor hepatoma liver mass
effect of pertubation on pregnancy rates before intrauterine insemination treatment

Conditions: Infertility; Pertubation; Insemination

Summary: to demonstrate a possible beneficial impact of pertubation we designed a randomized prospective study, in which uterine washing was administered prior to insemination in patients diagnosed with unexplained infertility.


Eligibility criteria:
inclusion criteria: * age of 18-44 years; presence of regular menstrual cycles and ovulation; absence of tubal occlusion on hsg; sperm concentration \>15 million spermatozoa/ml and total sperm number \>39 million/ml according to who criteria exclusion criteria: * the presence of endocrinologic disease; use of nonsteroidal anti-inflammatory drugs (nsaids) or corticosteroids; clinical findings suggestive of pelvic inflammatory disease; and the presence of undiagnosed uterine bleeding

Keywords: unexplained infertility, pertubation, gonadotrophin, ovulation induction, intrauterine insemination
study to evaluate the clinical efficacy and safety of subcutaneously administered c1 esterase inhibitor for the prevention of angioedema attacks in adolescents and adults with hereditary angioedema

Conditions: Hereditary Angioedema (HAE)

Summary: the purpose of this study is to assess the efficacy and safety of subcutaneous administration of a liquid formulation of c1 esterase inhibitor for the prevention of angioedema attacks in adolescent and adult subjects with hereditary angioedema.


Eligibility criteria:
the maximum duration of participation is approximately 9 months. patients will complete a screening period of up to 21 days. following screening, eligible patients will be randomly assigned to 1 of 3 treatment sequences. each patient will undergo 2 14-week treatment periods for a total of 28 weeks (treatment period 1 and treatment period 2). after completing the 2 treatment periods, patients will enter a 1-month follow-up period.
effects of computer assisted cognitive rehabilitation on patients with stroke

Conditions: Stroke

Summary: this study aims to investigate the effects of computer assisted cognitive rehabilitation and conventional cognitive rehabilitation methods on patients' attention, quality of life and functional independence. recruiting from 15 patients from each group, patients will be followed up for a month and the outcome measures will be repeated.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age with stroke exclusion criteria: * problems with sight * comorbid neurological disease * cognitive impairment prior to stroke * neglect syndrome * wernicke or global aphasia
preventing recurrent 'idiopathic' acute pancreatitis through laparoscopic cholecystectomy (picus-2)

Conditions: Idiopathic Acute Pancreatitis

Summary: rationale: annually, acute pancreatitis is diagnosed in 6,500 patients in the netherlands. in up to 25% of patients no definitive cause can be determined after routine work-up including endoscopic ultrasound and this is deemed to be idiopathic acute pancreatitis (iap). iap is known for its high recurrence rate. it is hypothesized that microlithiasis, a type of biliary pancreatitis, is the most common cause of iap. laparoscopic cholecystectomy (lc) is highly effective in preventing recurrence of biliary pancreatitis. currently no randomized trial has compared lc with conservative treatment in patients with iap after adequate work-up including endoscopic ultrasound. objective: to assess the effectiveness of lc as compared to conservative treatment in patients after a first episode of 'eus-negative' iap. study design: multicenter randomized controlled trial. patients will be followed for one year after randomization. study population: adults with a first episode of 'eus-negative' iap. intervention (if applicable): laparoscopic cholecystectomy versus conservative treatment. main study parameters/endpoints: the primary endpoint is pancreatitis recurrence. secondary endpoints include occurrence of biliary events, complications of lc, number and severity of recurrent episodes of pancreatitis, quality of life (qaly), costs (hospital and societal) and cost-effectiveness.


Eligibility criteria:
inclusion criteria: * at least 18 years old * eligible for early (laparoscopic)\* cholecystectomy * full required diagnostic work-up of patient has been performed, including eus * first episode of 'eus-negative' iap * informed consent for participation was obtained \*if required open cholecystectomy is allowed exclusion criteria: * recurrent acute pancreatitis * diagnosis of chronic pancreatitis * diagnosis of necrotizing pancreatitis * current pancreatic malignancy * prior cholecystectomy * documented etiology of acute pancreatitis
bicalutamide and ridaforolimus in men with prostate cancer (mk-8669-002)

Conditions: Prostate Cancer

Summary: this study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.

ridaforolimus (mk8669/ap23573) was also known as deforolimus until may 2009.

Eligibility criteria:
inclusion criteria: * confirmed adenocarcinomas of the prostate. * evidence of metastatic disease * evidence of disease progression including one of the following: increasing levels of psa, progressive lymph node disease, or worsening bone scan * psa level is greater or equal to 7 ng/ml. * ecog performance status less than or equal to 1 exclusion criteria : * previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long). * prior chemotherapy for prostate cancer * prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus. * patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer * patient has pain related to prostate cancer that warrants the initiation of chemotherapy
clinical application of near-infrared fluorescence guided localization on breast surgery in breast cancer

Conditions: Breast Cancer

Summary: near-infrared (nir) fluorescence imaging using indocyanine green (icg) has been used for breast cancer surgery such as sentinel lymph node (sln) mapping and breast cancer localization. in this study, our hypothesis are as following: 1. as inject only indocyanine green (icg), it provide the surgeon visual guidance to ensure better outcome. 2. indocyanine green (icg) permitted accurate preoperative and intraoperative detection of the slns as well as nonpalpable benign brest lesion in patients with breast cancer.

indocyanine green, icg (icg-fluorescence) * icg is the most commonly used fluorophore which approve by fda. * nir-f imaging with icg could be used in various surgeries. for example, sln mapping in breast cancer and localization of liver metastasis, especially superficial lesion * contains sodium iodide, patients who have history of allergy to iodides should be used as caution. nonpalpable benign brest lesion localization * new method for the localization and resection of non-palpable breast lesions. * the breast lesion was correctly localized, and the area of icg corresponded well to the site of the lesions.

Eligibility criteria:
inclusion criteria: * nonpalpable breast tumor ≤ 2cm in patients with breast cancer. * patients who need breast biopsy as treatment for breast cancer. * eastern cooperative oncology group performance status 0 or 1 * consented patients with more than 20 years, less than 70 years exclusion criteria: * nonpalpable breast tumor ≥ 2cm in patients with breast cancer. * pregnancy * history of severe allergy to icg(indocyanine green) * iode hypersensitiveness

Keywords: near-infrared fluorescence indocyanine green, icg breast cancer
postoperative delirium and its biomarkers in elderly patients undergoing non-cardiac and non-neurosurgery.

Conditions: Anesthesia; Postoperative Delirium

Summary: postoperative delirium (pod) is a common complication in elderly patients and is associated with negative clinical outcomes, such as prolonged hospitalizations, cognitive impairment, and higher mortality rate. while the pathophysiology of delirium remains unknown, the cerebral hypoperfusion and neuroinflammatory response are considered to play an important role in the process of pod. the aim of the study is to determine the association between pod and biomarkers in elderly patients undergoing noncardiac and non-neurological surgery.


Eligibility criteria:
inclusion criteria: * with american society of anesthesiologists (asa) physical status ⅱ-ⅳ * undergo elective non-cardiac and non-neurological surgery receiving general anesthesia * operation time is expected to be longer than 2 hours exclusion criteria: * clinical diagnosis of dementia * clinical diagnosis of cerebrovascular disorders * clinical diagnosis of heart failure * clinical diagnosis of liver failure * clinical diagnosis of renal failure * clinical diagnosis of traumatic brain injury * alcohol abuse * can not complete the cognitive assessments * refuse to sign informed consent
study of specimens from young patients with neuroblastoma

Conditions: Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Regional Neuroblastoma; Stage 4S Neuroblastoma

Summary: this research trial studies specimens from young patients with neuroblastoma. studying the genes expressed in specimens from patients with cancer may help doctors identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.

primary objectives: i. establish a robust messenger ribonucleic acid (mrna) gene expression classifier for improved outcome prediction in children with neuroblastoma by using real-time polymerase chain reaction (pcr) to quantify mrna levels from genes that have been shown in at least 2 independent studies to have predictive power. ii. identify microrna (mirna) patterns that have prognostic significance in neuroblastoma (nb) as accumulating evidence indicates that alterations in mirna expression play a critical role in tumorigenesis and can be used in prognostic evaluation. iii. to perform an integrated analysis of the established microrna classifier with our mrna signature to determine whether it results in even better classification of nb tumors. outline: previously collected samples are analyzed for 59 prognostic genes by real-time quantitative pcr-based gene expression profiling.

Eligibility criteria:
inclusion criteria: * diagnosis of primary neuroblastoma * untreated disease * rna samples from primary untreated nb-tumors available in children's oncology group (cog) repository * at least 60% tumor cells * at least 2 years of follow-up from the date of diagnosis * full clinical and biological annotation
study of t900607-sodium in previously treated patients with non-hodgkin's lymphoma.

Conditions: Non-Hodgkin's Lymphoma

Summary: the purpose of the study is to determine whether t900607-sodium is effective and safe in treating non-hodgkin's lymphoma.


Eligibility criteria:
inclusion criteria * histologically or cytologically confirmed diagnosis of non-hodgkin's lymphoma (nhl) * subjects must have received prior chemotherapy for their nhl * at least 18 years of age * bidimensionally measurable disease amenable to ct scanning. at least one lesion must be least 1 x 1 cm in size. * karnofsky performance status of at least 70% * estimated life expectancy of at least 12 weeks * females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive * subject must be able to comply with study procedures and follow-up examinations. * signed written informed consent * lab values (obtained ≤ 7 days prior to study enrollment): * anc at least 1.5x10e9/l, * platelet count at least 100x10e9/l, * hemoglobin at least 8.5 g/dl, * creatinine within 2 times upper limit of normal, * ast and alt within 3 times upper limit of normal, * bilirubin within 1.5 times upper limit of normal, * albumin great than 2.5 g/dl, exclusion criteria * severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment * nyha class iii/iv cardiac disease, left ventricular ejection fraction (lvef) of \<50%, or acute anginal symptoms * patients who have received any investigational agent within 4 weeks of enrollment * patients who are pregnant or breast-feeding * history of prior malignancy other than nhl within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * history of central nervous system metastases or carcinomatous meningitis * major surgery within 4 weeks of enrollment

Keywords: nhl
immunoregulatory effects of immunoglobulin induction therapy in renal transplant recipients

Conditions: Renal Failure, Chronic; Renal Transplantation

Summary: the aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an ivig induction therapy. furthermore clinical endpoints (patient and graft survival, incidence of acute and chronic rejection, infectious diseases and graft function) up to three years posttransplant will be analyzed.

intravenous immunoglobulin (ivig) preparations are known to be effective in the treatment of various autoimmune and inflammatory disorders due to their immunomodulatory and antiinflammatory properties. it has been demonstrated that ivig is effective in the treatment of acute vascular rejection and steroid resistant cellular rejection. furthermore, ivig has been used to inhibit production of lymphocytotoxic antibodies in highly sensitized patients so that successful cadaveric or living renal transplantation could be performed. the aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an ivig induction therapy on th1, th2 and b-cell/monocyte responses, expression of adhesion molecules, costimulatory factors and cytokine receptors and on secretion of immunoregulatory autoantibodies (anti-f(ab)-, anti-f(ab')2g-, anti-hinge autoantibodies). these autoantibodies have been shown to significantly affect the risk of chronic rejection and graft loss. furthermore, clinical endpoints (patient and gaft survival, incidence of acute and chronic rejection, infectious diseases and graft function) up to 3 years will be analyzed.

Eligibility criteria:
inclusion criteria: * renal transplant recipients of the giessen renal transplant unit * cadaveric and living renal transplants * first and retransplants exclusion criteria: * contraindications against blood-taking (anaemia with hemoglobin \< 9,5 g/l, hypotension) * intravenous immunoglobulin therapy in the last half year before study entry * hyperimmunoglobulin therapy for severe cmv infection * pregnancy

Keywords: immunoglobulins, intravenous kidney transplantation acute rejection chronic rejection regulatory autoantibodies th1 th2 b cell monokines cytokine promoter gene polymorphisms
evaluation of flow diverter technology device for intracranial aneurysm (shield)

Conditions: Aneurysm

Summary: the jacobs institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the pipeline™ flex embolization device with shield technology™ for the endovascular treatment of adults (22 years of age or older) with wide-necked intracranial aneurysms

the pipeline™ flex embolization device with shield technology™ for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments. the pipeline™ flex embolization device with shield technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio \< 2) saccular or fusiform intracranial aneurysm (ias) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.

Eligibility criteria:
inclusion criteria: * adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments. exclusion criteria: exclusion criteria: * cannot provide consent or legally authorized representative not available to provide consent criteria:
adjuvant therapeutic cancer vaccine (ast-201, pumvc3-higfbp-2) in patients with advanced ovarian cancer

Conditions: Advanced Ovarian Cancer

Summary: the purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine ast-201 (pumvc3-higfbp-2) in patients with newly diagnosed homologous-recombination proficient(hrp) advanced ovarian cancer (stage iii) after debulking surgery. patients will receive ast-201 with rhugm-csf(colony stimulating factor) or placebo with rhugm-csf in combination with standard adjuvant chemotherapy(paclitaxel/carboplatin).

the study will comprise a screening period of -28 days prior to initiation of study treatment (day 1); an enrollment period of 24 months; the treatment duration will be approximately of 5 months. the study will evaluate whether the addition of ast-201/rhugm-csf to the standard adjuvant chemotherapy will extend the progression free survival(pfs) rate. survival follow-up will be performed every 3 months (±14 days) after the end of treatment (eot) visit for 2 years after randomization and every 6 months (±28 days) thereafter until disease progression or death from any cause or withdrawal of consent whichever comes first. survival follow-up visits will be conducted by telephone, in-person visit, or chart review. the end of study (eos) is defined as 2 years after the date of last patient enrollment.

Eligibility criteria:
inclusion criteria: * newly diagnosed stage iii (figo classification) epithelial ovarian cancer including primary peritoneal cancer, fallopian-tube cancer * has received upfront surgery and optimally debulked(a residual tumor less than 1 cm) * can start adjuvant therapy within 6 weeks of debulking surgery * has homologous recombination proficiency (hrp) tumor defined by fda-approved testing * eastern cooperative oncology group (ecog) performance status of 0 or 1 * demonstrates adequate organ function. exclusion criteria: * has a history of hypersensitivity or other contraindications to rhugm-csf * has a history of active malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease * is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs * has active or prior autoimmune disease or inflammatory disease * has active infectious disease including tuberculosis, hepatitis b, hepatitis c or human immunodeficiency virus (hiv) infection * is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study

Keywords: cancer vaccine phase 2 study advanced ovarian cancer homologous-recombination proficient (hrp)
a prospective observational study about adjuvant or neoadjuvant chemotherapy related adverse effects in premenopausal breast cancer patients

Conditions: Breast Cancer

Summary: breast cancer is one of the most common malignant tumor in women. about 60% of breast cancer patients are still in premenopausal status at the time of diagnosis in china. it is a multicenter prospective observational study. we will collect basic information, medical history, chemotherapy-related adverse reactions, and the results of hormone, blood lipid, and bone density test before, during and after adjuvant or neoadjuvant chemotherapy. the aim of the study is to evaluate the effect of chemotherapy on ovarian function and fertility and the protective effect of gnrha. in addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.

breast cancer is one of the most common malignant tumor in women, and it occurs at a younger median age in chinese women than in western white women. about 60% of breast cancer patients are still in premenopausal status at the time of diagnosis in china. chemotherapy is one of the important treatments for breast cancer, but it brings a series of adverse effects. it is a multicenter prospective observational study. the premenopausal breast cancer women patients who are planning adjuvant or neoadjuvant chemotherapy are enrolled in the study after signing the informed consent form and passing the screening. we collect their basic information, medical history, chemotherapy-related adverse reactions, and the results of hormone, blood lipid, and bone density test before, during and after chemotherapy. the aim of the study is to evaluate the effect of adjuvant or neoadjuvant chemotherapy on ovarian function and fertility and the protective effect of gnrha by investigating the menopausal symptoms, pregnancy, menstruation condition, hormone levels, blood lipid, bone density, and the usage of gnrha in the premenopausal women with breast cancer. in addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.

Eligibility criteria:
inclusion criteria: 1. informed consent form has been signed. 2. breast cancer patients whose age is ≥ 18 years old and have been diagnosed by histological examination. 3. plan for adjuvant or neoadjuvant chemotherapy exclusion criteria: 1. postmenopausal women who are defined by any of the following: * previous bilateral oophorectomy; * age ≥ 60 years old; * age \<60 years old, menopause at least 12 months, and follicle stimulating hormone \[fsh\] and estradiol levels in the postmenopausal range. 2. those who have already received adjuvant or neoadjuvant chemotherapy. 3. those who have chemotherapy contraindications. 4. those who have any mental condition that prevents the understanding of the contents of this study and can't provide the complete information required.